The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A

NCT01127282 | Unknown Phase 4 DMC

• 1 other identifier: Vitamin_H1N1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza continues to inflict an important burden on health-care systems. The 2009 H1N1 influenza virus first appeared in Mexico and the United States in March and April 2009 and has swept the globe with unprecedented speed. The aim of this study is to evaluate effect of supplement vitamin on the clinical course of patients with acute respiratory illness suspected novel H1N1 infection.

Conditions

H1N1 Influenza

Keywords

influenza; vitamin; improvement of symptom

Outcome Measures

Primary Outcomes (1)

• change of symptom score

  1 week after initial visit

Study Arms (2)

Vitamin

EXPERIMENTAL

Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics

Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)

Control

PLACEBO COMPARATOR

Placebo(digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics

Drug: Placebo (digestive tablet)

Interventions

Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) DRUG

Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics

Vitamin

Placebo (digestive tablet) DRUG

Placebo (digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 20 years
• Acute respiratory illness suspected H1N1 infection
• Acute febrile respiratory illness(BT \> 37.8) and throat pain or cough or nasal congestion

You may not qualify if:

• Pregnancy
• Hypersensitivity to vitamin A
• History of liver disease or renal disease
• Urinary stone disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

RECRUITING

MeSH Terms

Conditions

Orthomyxoviridae Infections; Influenza, Human

Interventions

Vitamins; Vitamin A; Digestion

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Nutritional Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Chang-Hoon Lee, MD

  Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center

  STUDY CHAIR

Central Study Contacts

Chang-Hoon Lee, MD

CONTACT

+82- 2- 870- 2232; kauri670@gmail.com

Jong Sun Park, MD

CONTACT

jspark.im@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 20, 2010

Record last verified: 2010-05

Locations

KR (1)